STETHOSCOPE, ADULT, STNLSS STL,GRY

Additional Manufacturer Narrative

ACCORDING TO THE CUSTOMER, ON (B)(6) 2025, THE USER PLACED THE STETHOSCOPE TO THEIR EARS WITHOUT KNOWING THE "EAR BUD HAD FALLEN OFF" RESULTING IN A LACERATION OF THE LEFT EAR CANAL AND PERFORATED TYMPANIC MEMBRANE. THE CUSTOMER STATED THAT THE USER WENT TO URGENT CARE AND AN ENT PROVIDER FOR TREATMENT AND COMPLAINED OF SEVERE PAIN, RINGING IN THE EAR, MUFFLED HEARING, AND BLEEDING. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT CAUSED OR CONTRIBUTED TO SERIOUS INJURY, THEREFORE, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

Description of Event or Problem

ACCORDING TO THE CUSTOMER, ON (B)(6) 2025, THE USER PLACED THE STETHOSCOPE TO THEIR EARS WITHOUT KNOWING THE "EAR BUD HAD FALLEN OFF" RESULTING IN A LACERATION OF THE LEFT EAR CANAL AND PERFORATED TYMPANIC MEMBRANE. THE CUSTOMER STATED THAT THE USER WENT TO URGENT CARE AND AN ENT PROVIDER FOR TREATMENT AND COMPLAINED OF SEVERE PAIN, RINGING IN THE EAR, MUFFLED HEARING, AND BLEEDING.